UrogenitalPEENCT05354921
Indwelling vs Intermittent Catheterization Pilot Study
A study testing Indwelling Catheter and Intermittent Catheterization in people with Urogenital and Urinary Tract Infections, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Urogenital, Urinary Tract Infections, Hip Fractures
- What is being tested?
- Indwelling Catheter and Intermittent Catheterization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2022to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip fracture (intertrochanteric, femoral neck, femoral head, sub-trochanteric) confirmed by imaging
- Age ≥50 years
- Operative treatment planned
- Admitted under Orthopaedic Surgery
- Willing and able to sign consent (substitute decision maker)
Who cannot join
- Periprosthetic hip fracture
- Polytrauma
- Multiple fractures of the lower limbs
- Previous lower urinary tract surgery
- Known (past or current) urogenital cancer (prostate, bladder)
- Urinary tract infection prior to randomization
- Indwelling catheter present on admission (chronic or placed at previous acute setting)
Trial locations and contacts
1 site in 1 country.
George Grammatopoulos, MD contact
Canada1 site
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Isabel S Horton, 6137378899 ext. 73032, ihorton@ohri.ca
About this study
Official title: Hip Fracture Patient and the Use of IndwElling vs IntermittEnt Catheterization Pilot Study
The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization. The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this pilot study trial and proceed towards a multi-center trial.
Read the detailed description
The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization.
The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this vanguard trial and proceed towards a multi-center trial.
Secondary objectives would be related to safety and patient activity that would be important endpoints for the definitive, large scale trial. These would include the following:
- Is short term indwelling catheter use associated with reduced incidence of UTI compared to clean intermittent catheterization in patients with hip fracture.
- How does patient experience compare between these two forms of treatment?
Eligible patients will be approached for consent at admission and, if willing to participate, will be randomized into Group A or Group B using a web-based, computer-generated randomization with permuted blocks of varying sizes.
Data Collection will include:
- Urinary symptoms at admission, pre-fracture
- Date and time of catheter insertion (indwelling or not)
- Date and time of surgery
- Type of anesthesia used
- Date and time of catheter removal
- Number of catheterizations performed during hospital stay
- Type of Antibiotic cover during per-operative period (typically 3 doses provided perioperatively)
A clinical research coordinator (CRC) will oversee study recruitment and assess number of study participants to the total number of patients admitted with a hip fracture which will allow for documentation of ability to recruit into the study. Furthermore, the CRC will prospectively record each patent's journey to assess whether enrolled patients are receiving the treatment they are randomized to. All enrolled patients will be asked to fill in a patient satisfaction score that has been in use already at our institution.
A CRC, blinded to the arm patients were randomized to, will be responsible for recording all outcome measures of interest prospectively in the study's database from the participant's electronic medical records. Validity of data extraction will be tested for a randomly selected 10% of the cohort by a second evaluator (CRC not previously involved in the study).
Data analyses will include:
Descriptive Statistics: Given the feasibility purpose of the vanguard trial, descriptive statistics will be used to summarize demographics and baseline prognostic factors of participants allocated to the two trial arms.
Analysis of Primary Outcome: Our primary endpoint is the rate of enrolment to ensure the ability to undertake a larger multi-centered trial. An average rate of 10 patients/month or greater will be considered as ideal for establishing feasibility. An enrollment of less than 5 patients/month will likely jeopardize the ability to feasibly recruit for the larger trial. Whereas, average monthly enrolment of 5 to 10 patients will require a re-evaluation of our recruitment strategy, intervention specifications, and/or eligibility criteria to improve enrolment.
Analysis of Secondary Outcomes: Given the vanguard nature of this trial, the investigators will not undertake inferential analyses of our secondary outcomes but rather these patients will be carried forward into the larger trial.
- Being tested
- Indwelling Catheter, Intermittent Catheterization
- Medical subject headings
- Urinary Tract Infections, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indwelling CatheterDevice
Patients in the experimental group will receive foley catheter upon admission, aseptically. The catheter will be discontinued on the morning following surgery. At TOH most (>75%) hip fractures are treated within 48 hours of admission and 95% within 72 hours and hence the indwelling catheter is likely to stay in place for 3-4 days.
Intermittent CatheterizationDevice
Patients randomized to the intermittent catheterization group will have their PVR monitored every 8 hours pre-operatively. If PVR>400 mL, an intermittent catheter will be used. If PVR> 400 mL greater than 3 times pre-operatively, an indwelling catheter will be placed the fourth time. The indwelling catheter will be removed the morning of post-op day 1.
It is expected that a small percentage of patients in either group will not have a PVR>400 mL preoperatively.
These patients will not be catheterized but will remain in the study. Post-operatively, both treatment groups will have their PVR monitored for 24 hours, or until PVR is less than 200 mL. If PVR>400 mL and the patient is not able to void further, intermittent catheterization will be done every six hours as needed. If post-operative PVR>400 mL greater than 3 times post-operatively, an indwelling catheter will be placed the fourth time.
| Study group | Role | What they receive |
|---|---|---|
| Indwelling | Experimental | Foley catheterization upon admission and removed the morning following surgery. Receives: Device: Indwelling Catheter |
| Intermittent | Experimental | Intermittent catheterization when post-void residual volume is greater than 400 mL. Receives: Device: Intermittent Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility - Enrollment
Number of participants enrolled and willingness of participants to be randomized Comparing the Number of patients screened compared to the number of patients meeting eligibility criteria.
Tracking crossover between the treatment groups, participant retention, and follow-up rates.
Measured: One year
Study Feasibility - Screening
Number of patients screened and number meeting eligibility
Measured: One year
Study Feasibility - Retention
Participant retention rate in study
Measured: One year
Study Feasibility - Follow-up
Rates of participant follow-up
Measured: One year
Secondary outcomes (3)
Safety-Related Outcomes - Rates of UTI
Number of patients who present with a post-operative UTI within 30 days of catheterization
Measured: 30 days
Safety-Related Outcomes - Rates of POUR
Number of patients who present with post-operative POUR within 30 days of catheterization
Measured: 30 days
patient experience questionnaire
the patient experience questionnaire, created by the principal investigator of the study, will be used to assess patients level of urogenital pain and discomfort and satisfaction with catheterization.
Measured: pre-operatively, and post-operative day six or at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study startJun 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for UrogenitalStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital
- Responsible party
- Sponsor
- Investigators
- George Grammatopoulos, MD, Principal investigator, The Ottawa HospitalSteven Papp, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354921
- Sponsor's protocol ID
- 20220067-01H
- Acronym
- PEE
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Health Quality Ontario, M.o.H.a.L.-T.C., Quality Based Procedures Clinical Handbook for Hip Fracture. 2013.
Dodd AC, Bulka C, Jahangir A, Mir HR, Obremskey WT, Sethi MK. Predictors of 30-day mortality following hip/pelvis fractures. Orthop Traumatol Surg Res. 2016 Oct;102(6):707-10. doi: 10.1016/j.otsr.2016.05.016. Epub 2016 Aug 3.
PubMed 27496661Skelly JM, Guyatt GH, Kalbfleisch R, Singer J, Winter L. Management of urinary retention after surgical repair of hip fracture. CMAJ. 1992 Apr 1;146(7):1185-9.
PubMed 1555145Smith NK, Albazzaz MK. A prospective study of urinary retention and risk of death after proximal femoral fracture. Age Ageing. 1996 Mar;25(2):150-4. doi: 10.1093/ageing/25.2.150.
PubMed 8670545Hedstrom M, Grondal L, Ahl T. Urinary tract infection in patients with hip fractures. Injury. 1999 Jun;30(5):341-3. doi: 10.1016/s0020-1383(99)00094-7.
PubMed 10505128Kamdar A, Yahya A, Thangaraj L. Retrospective observational study of the incidence of short-term indwelling urinary catheters in elderly patients with neck of femur fractures. Geriatr Gerontol Int. 2009 Jun;9(2):131-4. doi: 10.1111/j.1447-0594.2008.00490.x.
PubMed 19740355Schneider MA. Prevention of catheter-associated urinary tract infections in patients with hip fractures through education of nurses to specific catheter protocols. Orthop Nurs. 2012 Jan-Feb;31(1):12-8. doi: 10.1097/NOR.0b013e3182419619.
PubMed 22278644Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
PubMed 20156062Thomas S, Harris N, Dobransky J, Grammatopoulos G, Gartke K, Liew A, Papp S. Urinary catheter use in patients with hip fracture: Are current guidelines appropriate? A retrospective review. Can J Surg. 2021 Nov 25;64(6):E630-E635. doi: 10.1503/cjs.014620. Print 2021 Nov-Dec.
PubMed 34824151Excellence, N.I.f.H.a.C., Hip fracture: management. 2011.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Fracture Patient and the Use of IndwElling vs IntermittEnt Catheterization Pilot Study
- ClinicalTrials.gov ID
- NCT05354921
- Acronym / sponsor ID
- PEE / 20220067-01H
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital
- Study start
- Jun 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization. The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this pilot study trial and proceed towards a multi-center trial.
Detailed description
The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization.
The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this vanguard trial and proceed towards a multi-center trial.
Secondary objectives would be related to safety and patient activity that would be important endpoints for the definitive, large scale trial. These would include the following:
- Is short term indwelling catheter use associated with reduced incidence of UTI compared to clean intermittent catheterization in patients with hip fracture.
- How does patient experience compare between these two forms of treatment?
Eligible patients will be approached for consent at admission and, if willing to participate, will be randomized into Group A or Group B using a web-based, computer-generated randomization with permuted blocks of varying sizes.
Data Collection will include:
- Urinary symptoms at admission, pre-fracture
- Date and time of catheter insertion (indwelling or not)
- Date and time of surgery
- Type of anesthesia used
- Date and time of catheter removal
- Number of catheterizations performed during hospital stay
- Type of Antibiotic cover during per-operative period (typically 3 doses provided perioperatively)
A clinical research coordinator (CRC) will oversee study recruitment and assess number of study participants to the total number of patients admitted with a hip fracture which will allow for documentation of ability to recruit into the study. Furthermore, the CRC will prospectively record each patent's journey to assess whether enrolled patients are receiving the treatment they are randomized to. All enrolled patients will be asked to fill in a patient satisfaction score that has been in use already at our institution.
A CRC, blinded to the arm patients were randomized to, will be responsible for recording all outcome measures of interest prospectively in the study's database from the participant's electronic medical records. Validity of data extraction will be tested for a randomly selected 10% of the cohort by a second evaluator (CRC not previously involved in the study).
Data analyses will include:
Descriptive Statistics: Given the feasibility purpose of the vanguard trial, descriptive statistics will be used to summarize demographics and baseline prognostic factors of participants allocated to the two trial arms.
Analysis of Primary Outcome: Our primary endpoint is the rate of enrolment to ensure the ability to undertake a larger multi-centered trial. An average rate of 10 patients/month or greater will be considered as ideal for establishing feasibility. An enrollment of less than 5 patients/month will likely jeopardize the ability to feasibly recruit for the larger trial. Whereas, average monthly enrolment of 5 to 10 patients will require a re-evaluation of our recruitment strategy, intervention specifications, and/or eligibility criteria to improve enrolment.
Analysis of Secondary Outcomes: Given the vanguard nature of this trial, the investigators will not undertake inferential analyses of our secondary outcomes but rather these patients will be carried forward into the larger trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indwelling | Experimental | Device: Indwelling CatheterFoley catheterization upon admission and removed the morning following surgery. |
| Intermittent | Experimental | Device: Intermittent CatheterizationIntermittent catheterization when post-void residual volume is greater than 400 mL. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hip fracture (intertrochanteric, femoral neck, femoral head, sub-trochanteric) confirmed by imaging
- Age ≥50 years
- Operative treatment planned
- Admitted under Orthopaedic Surgery
- Willing and able to sign consent (substitute decision maker)
Key exclusion criteria (7 listed)
- Periprosthetic hip fracture
- Polytrauma
- Multiple fractures of the lower limbs
- Previous lower urinary tract surgery
- Known (past or current) urogenital cancer (prostate, bladder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indwelling CatheterPatients in the experimental group will receive foley catheter upon admission, aseptically. The catheter will be discontinued on the morning following surgery. At TOH most (>75%) hip fractures are treated within 48 hours of admission and 95% within 72 hours and hence the indwelling catheter is likely to stay in place for 3-4 days. | Device | Indwelling |
| Intermittent CatheterizationPatients randomized to the intermittent catheterization group will have their PVR monitored every 8 hours pre-operatively. If PVR>400 mL, an intermittent catheter will be used. If PVR> 400 mL greater than 3 times pre-operatively, an indwelling catheter will be placed the fourth time. The indwelling catheter will be removed the morning of post-op day 1. It is expected that a small percentage of patients in either group will not have a PVR>400 mL preoperatively. These patients will not be catheterized but will remain in the study. Post-operatively, both treatment groups will have their PVR monitored for 24 hours, or until PVR is less than 200 mL. If PVR>400 mL and the patient is not able to void further, intermittent catheterization will be done every six hours as needed. If post-operative PVR>400 mL greater than 3 times post-operatively, an indwelling catheter will be placed the fourth time. | Device | Intermittent |
Primary outcome
Study Feasibility - Enrollment
Time frame: One year
Number of participants enrolled and willingness of participants to be randomized Comparing the Number of patients screened compared to the number of patients meeting eligibility criteria. Tracking crossover between the treatment groups, participant retention, and follow-up rates.
Study Feasibility - Screening
Time frame: One year
Number of patients screened and number meeting eligibility
Study Feasibility - Retention
Time frame: One year
Participant retention rate in study
Study Feasibility - Follow-up
Time frame: One year
Rates of participant follow-up
3 secondary outcomes
Safety-Related Outcomes - Rates of UTI
Time frame: 30 days
Safety-Related Outcomes - Rates of POUR
Time frame: 30 days
patient experience questionnaire
Time frame: pre-operatively, and post-operative day six or at discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- BackgroundHealth Quality Ontario, M.o.H.a.L.-T.C., Quality Based Procedures Clinical Handbook for Hip Fracture. 2013.
- Results publication: PubMed 27496661Dodd AC, Bulka C, Jahangir A, Mir HR, Obremskey WT, Sethi MK. Predictors of 30-day mortality following hip/pelvis fractures. Orthop Traumatol Surg Res. 2016 Oct;102(6):707-10. doi: 10.1016/j.otsr.2016.05.016. Epub 2016 Aug 3.
- Results publication: PubMed 1555145Skelly JM, Guyatt GH, Kalbfleisch R, Singer J, Winter L. Management of urinary retention after surgical repair of hip fracture. CMAJ. 1992 Apr 1;146(7):1185-9.
- Results publication: PubMed 8670545Smith NK, Albazzaz MK. A prospective study of urinary retention and risk of death after proximal femoral fracture. Age Ageing. 1996 Mar;25(2):150-4. doi: 10.1093/ageing/25.2.150.
- Results publication: PubMed 10505128Hedstrom M, Grondal L, Ahl T. Urinary tract infection in patients with hip fractures. Injury. 1999 Jun;30(5):341-3. doi: 10.1016/s0020-1383(99)00094-7.
- Results publication: PubMed 19740355Kamdar A, Yahya A, Thangaraj L. Retrospective observational study of the incidence of short-term indwelling urinary catheters in elderly patients with neck of femur fractures. Geriatr Gerontol Int. 2009 Jun;9(2):131-4. doi: 10.1111/j.1447-0594.2008.00490.x.
- Results publication: PubMed 22278644Schneider MA. Prevention of catheter-associated urinary tract infections in patients with hip fractures through education of nurses to specific catheter protocols. Orthop Nurs. 2012 Jan-Feb;31(1):12-8. doi: 10.1097/NOR.0b013e3182419619.
- Results publication: PubMed 20156062Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
- Results publication: PubMed 34824151Thomas S, Harris N, Dobransky J, Grammatopoulos G, Gartke K, Liew A, Papp S. Urinary catheter use in patients with hip fracture: Are current guidelines appropriate? A retrospective review. Can J Surg. 2021 Nov 25;64(6):E630-E635. doi: 10.1503/cjs.014620. Print 2021 Nov-Dec.
- Results publicationExcellence, N.I.f.H.a.C., Hip fracture: management. 2011.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Grammatopoulos, MD contact
George Grammatopoulos, MD principal investigator
The Ottawa Hospital
Steven Papp, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indwelling Catheter and Intermittent Catheterization in people with Urogenital and Urinary Tract Infections, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Horton (613-737-8899 ext. 73032, ihorton@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility - Enrollment (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05354921, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.